Medical devices are commonly packaged by form fill seal or F/F/S machines to place the devices in packages in which they can be sterilized and the sterilization maintained until usage. In order to verify the package integrity, a subset of packages from each batch processed by a machine are typically pulled and subject to testing for seal completeness. For packages made of a non-porous material, such tests are typically burst tests in which a needle is used to pressurize the package until the seal or package ruptures. Properly sealed packages will require at least a known pressure before bursting. However, for packages with a porous portion, such as a plastic package with a paper top, such burst testing does not work as the injected air flows through the porous portion of the package. Prior art attempts to address this issue by utilizing a sealing patch that is manually applied to the packaging web area that is to be punctured. However, such a seal can mask issues with the web area, for example holes in the porous portion that are covered by the seal, but which would represent a breach of the package integrity.
Some examples of known testing devices include those disclosed in the following U.S. Pat. No. 7,810,377, U.S. Pat. No. 6,640,614, U.S. Pat. No. 4,916,936, U.S. Pat. No. 4,459,843, U.S. Pat. No. 6,038,915, U.S. Pat. No. 4,539,836, U.S. Pat. No. 4,837,707, and U.S. Pat. No. 4,733,555, the contents of each of which are incorporated by reference herein in their entirety. However, current package burst test technology does not provide a reliable method for testing different types of packages directly on the F/F/S machine. Testing devices or methods that addressed these various shortcomings would be an improvement in the art.